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AIM:To evaluate the safety and efficacy of vitamin E in children with chronic hepatitis B.METHODS:We randomly assigned patients with chronic hepatitis B,positive for hepatitis B e antigen(HBeAg),to receive either vitamin E or placebo once daily for 6 mo in a 3:1 ratio and double-blind manner.The primary end point was HBeAg seroconversion,defined as the loss of HBeAg,undetectable levels of serum hepatitis B virus DNA,and the appearance of antibodies against HBeAg 12 mo after therapy.RESULTS:At baseline visit,49 patients had normal and 43 had increased serum aminotransferase levels.Twenty-nine patients did not respond to previous treatment with interferon-α or lamivudine.Seventy-six children completed the study;16 were non-compliant(n = 7),lost to follow-up(n = 7),or started another antiviral treatment(n = 3).Intention-to-treat analysis showed HBeAg seroconversion in 16 children(23.2%) treated with vitamin E and two(8.7%) in the placebo group(P = 0.13).Vitamin E was well tolerated.CONCLUSION:There is only a tendency that vitamin E may promote HBeAg seroconversion.Therefore larger studies are needed to clarify the role of antioxidants in the therapy of chronic hepatitis B.
AIM: To evaluate the safety and efficacy of vitamin E in children with chronic hepatitis B. METHODS: We randomly assigned patients with chronic hepatitis B, positive for hepatitis B e antigen (HBeAg), to receive either vitamin E or placebo once daily for 6 mo in a 3: 1 ratio and double-blind manner. The primary end point was HBeAg seroconversion, defined as the loss of HBeAg, undetectable levels of serum hepatitis B virus DNA, and the appearance of antibodies against HBeAg 12 mo after therapy .RESULTS : At baseline visit, 49 patients had normal and 43 had increased serum aminotransferase levels. Twenty-nine patients did not respond to previous treatment with interferon-alpha or lamivudine. Seventy-six children completed the study; 16 were non-compliant (n = Intention-to-treat analysis showed HBeAg seroconversion in 16 children (23.2%) treated with vitamin E and two (8.7% ) in the placebo group (P = 0.13). Vitamin E was well tolerated. CONCL USION: There is only a tendency that vitamin E may promote HBeAg seroconversion. Therefore larger studies are needed to clarify the role of antioxidants in the therapy of chronic hepatitis B.